BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-TECH GUIDEWIRE AND INTRODUCER SET

    MDR report key: 36411 · Received July 16, 1996

    Report

    Report Number
    36411
    Event Type
    Injury
    Date Received
    July 16, 1996
    Date of Event
    May 6, 1996
    Report Date
    May 20, 1996
    Manufacturer
    MEDI-TECH, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH UNSTABLE ANGINA WENT FOR L-HEART CATH & CINEARTERIOGRAMS. AT CONCLUSION OF PROCEDURE PORTION OF WIRE INTRODUCER FRACTURED DURING REMOVAL, REMAINING IN THE PT. CAUSED PERFORATION OF R-DEEP FEMORAL ARTERY AND HYPOTENSION REQUIRING TX W/PLASMANATE AND A RADIOLOGIC CONSULT. LARGE HEMATOMA IN PROFUNDA ARTERY AND 3-WIRE INTRODUCER FRAGMENTS WERE NOTED AND SUBSEQUENTLY REMOVED SURGICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH GUIDEWIRE AND INTRODUCER SET GUIDEWIRE AND INTRODUCER SET DQX MEDI-TECH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| O| R